Doctors in the north east of England could be facing legal action from two of the world's largest pharmaceutical companies for offering sufferers of a serious eye condition the choice of a safe, effective and cheaper drug, according to the BMJ.
It is estimated that prescribing Avastin (bevacizumab) could save the cash-strapped NHS up to £13.5m (€15.4m) in the region over the next five years, and £500m a year if rolled out across the service.
However, pharmaceutical giants Bayer and Novartis are warning they could take legal action, arguing that offering patients the cheaper drug would breach patients' legal right to an approved drug.
The eye condition in question is known as wet age related macular degeneration (AMD) – a leading cause of blindness in older patients. Currently, two drugs – Lucentis (ranibizumab) and aflibercept (Eylea) – manufactured by Bayer and Novartis are licensed to treat it.
While Avastin is not currently licenced for wet AMD, several trials have shown it is just as safe and effective as aflibercept and ranibizumab.
Patients in the region will be told they can have aflibercept and ranibizumab if they prefer but will be made aware of the cost savings to the NHS if they choose bevacizumab.
However, Bayer and Novartis argue that using unlicensed medicine undermines regulatory frameworks as well as the NHS constitution. "Bayer feels it has to act to challenge the decision taken by these Clinical Commissioning Groups," a Bayer spokesperson said.
Prescribing unlicensed drugs contravenes the General Medical Council's (GMC) guidelines.
"It's purely the regulatory framework that is stopping bevacizumab's widespread use in the NHS," Andrew Lotery, Professor of ophthalmology at Southampton University told The BMJ.
However, the GMC has said recently that it is "sympathetic to the frustrations of doctors and organisations seeking to use resources effectively".
Assistant Director of Standards and Ethics Mary Agnew said: "We hope that some sort of licensing solution for drugs such as Avastin may be forthcoming, or alternatively that the situation is clarified in the courts to give doctors more assurance about when they can prescribe this drug safely and within the law."
Professor Lotery added that his eye unit is experiencing "extreme pressure" due to a lack of capacity, like many services across the country.
"Savings made by using bevacizumab should be reinvested into the hospital eye service to build capacity to deliver sight saving treatment for age-related macular degeneration," he said.
Finally, David Hambleton, Chief Officer at South Tyneside Clinical Commissioning Group, argues that pharmaceutical companies "should not dictate which drugs are available to NHS patients. The choice between three clinically effective drugs should be one for NHS clinicians and patients to make together."
